FDA.reportPublic FDA data

free PSA Calset

Primary DI
07613336155400
Brand
free PSA Calset
Company
Roche Diagnostics GmbH
Model
03289796190
Catalog number
03289796190
Device description
free PSA CalSet-calibrator
Published
2017-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MTGTest,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign ConditionsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000027023

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000027023ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECKRoche Diagnostics Corp.2000-12-12LTJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630919338PreviousGS10
07613336155400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630919338040156309193384015630919338
07613336155400076133361554007613336155400

GMDN Terms#

Term, Definition table
TermDefinition
Free (unbound) prostate specific antigen (fPSA) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of free (unbound) prostate specific antigen (fPSA) in any of the isoforms [i.e., benign PSA (BPSA), inactive/intact PSA, and/or the PSA precursor, proPSA] in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590701680Access Hybritech free PSABeckman Coulter, Inc.MTG2025-05-30
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00380740158330AlinityAbbott Ireland DiagnosticsMTG2020-11-18
00380740158347AlinityAbbott Ireland DiagnosticsMTG2020-11-18
07613336166673Elecsys free PSARoche Diagnostics GmbHMTG2020-08-27
07613336166628Elecsys free PSARoche Diagnostics GmbHMTG2020-08-26
07613336168134free PSA CalSetRoche Diagnostics GmbHMTG2020-08-26
04015630940011Elecsys free PSARoche Diagnostics GmbHMTG2018-08-23
07613336154403free PSA CalCheckRoche Diagnostics GmbHMTG2018-06-29
07613336154397Elecsys free PSARoche Diagnostics GmbHMTG2017-09-29
04015630997053Elecsys Free PSA CalCheckRoche Diagnostics GmbHMTG2014-12-18
00380740009007ARCHITECTAbbott Ireland DiagnosticsMTG2014-11-18
00380740009014ARCHITECTAbbott Ireland DiagnosticsMTG2014-11-18
00380740009021ARCHITECTAbbott Ireland DiagnosticsMTG2014-11-18
00842768013751Dimension® clinical chemistry system T/F PSA CalibratorSiemens Healthcare Diagnostics Inc.MTG2014-09-24
00842768013881Dimension® clinical chemistry system FPSA Flex® reagent cartridgeSiemens Healthcare Diagnostics Inc.MTG2014-09-24
00842768016677Dimension Vista® System FPSA Flex® Reagent CartridgeSiemens Healthcare Diagnostics Inc.MTG2014-09-24
00842768024214Dimension Vista® System PSA CALSiemens Healthcare Diagnostics Inc.MTG2014-09-24
00630414971575IMMULITE®/IMMULITE®1000 Systems fPS Free PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTG2014-09-24
00630414977478IMMULITE® 2000 Systems fPS Free PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTG2014-09-24
H628372101Access Hybritech free PSABeckman Coulter, Inc.MTG2014-09-16
H628372151Access Hyritech free PSA CalibratorsBeckman Coulter, Inc.MTG2014-09-16
04015630919338Elecsys Free PSA CalSetRoche Diagnostics GmbHMTG2014-09-10
04015630919321Elecsys Free PSA ImmunoassayRoche Diagnostics GmbHMTG2014-09-09